Synthetech - Manufacturer of Peptide Building Blocks, Specialty Amino Acids and Chiral Intermediates

Synthetech is an international leader in the manufacture of peptide building blocks, specialty amino acids, chiral intermediates and peptide fragments utilized for the manufacture of peptide therapeutics, peptidomimetics and small molecule drugs. These products are also used in innovative cosmetic products. Since its founding in 1981, Synthetech has provided over 400 different peptide building blocks in volumes ranging from gram scale for drug discovery and clinical development, through multi-ton production for marketed, commercial products.

DIVERSE CHIRAL PRODUCT OFFERING

Synthetech's product line includes a wide range of both amine group and side-chain protected amino acids (FMOC, BOC, CBZ, etc.). The company's manufacture of specialty, non-natural amino acids is well established. Products include naphthylalanine, pyridylalanine and numerous substituted phenylalanines. Synthetech manufactures di, tri and tetra-peptides in solution phase and a 10s to 100s kgs scale.

FINE CHEMICAL MANUFACTURING FACILITY

Synthetech operates over 55m³ (14K gallon) of capacity in glass-lined and stainless steel reactors ranging in size from 20 to 10,000 liters (5 to 2,500 gallon). The company is large enough to own and apply the appropriate technology and equipment to efficiently and cost-effectively complete a project, and small enough to be responsive and flexible in serving customers.

Over the past five years, Synthetech has invested nearly $20 million for the strategic expansion of infrastructure and capabilities, including construction of a $15 million large-scale multipurpose manufacturing facility (with empty bays for further expansion). Within the past two years the R&D and Quality Control labs have been completely remodeled and equipped with state-of-the-art equipment and instrumentation. An on-site wastewater treatment facility was brought on-line in 2002.

ENZYMATIC AND CHEMICAL MANUFACTURE TECHNOLOGY

Synthetech's goal is to continue the development and implementation of the most cost-effective processes for the manufacture of the products its clients need. Synthetech possesses extensive experience in both enzymatic and chemical manufacture methods. Enzymatic methods include acylase, alcalase and hydantoinase resolutions. Asymmetric hydrogenation and other chiral methods are being applied for a broad range of products.

MANUFACTURE OF SMALL PEPTIDES VIA SOLUTION PHASE SYNTHESIS

Synthetech also has expertise in the solution phase manufacture of small peptides. The choice of protecting group, activating group, order of addition and coupling agent leads to numerous alternate potential peptide synthesis routes. Synthetech's experience in the manufacture of the protected amino acids, as well as the solution phase coupling, allows quick targeting of the most cost-effective process.

MANUFACTURE OF DOWN-STREAM CHIRAL INTERMEDIATES

Synthetech also initiates custom manufacturing of complex down-stream chiral intermediates. The chemistry required for these derivatives, including hydrogenation, Grignard and hydride additions, condensations and others, are practiced at Synthetech on a multi-ton scale.

NEW PRODUCT / SERVICE INNOVATION

Synthetech is actively developing and implementing technology to expand its product line. A new hard-copy and on-line catalog features beta-amino acids, homo-beta-amino acids and pre-loaded amino acid resins. Customers can log into the Synthetech website to browse and purchase products using their corporate credit cards.

SAFETY / QUALITY

Synthetech is committed to the delivery of high-quality products and to the operation of a safe and environmentally responsible facility. Our quality program includes the commitment to manufacture within a cGMP environment and has been certified by numerous customer audits of our facilities. Synthetech safety and environmental programs have been recognized by outside organizations, including receipt of the SOCMA Responsible Care Achievement Award (2001 and 2002) and a certificate of recognition by Oregon OSHA under its Safety and Health Achievement Recognition Program (2003).